[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR316.31]

[Page 177]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 316--ORPHAN DRUGS--Table of Contents
 
                Subpart D--Orphan-drug Exclusive Approval
 
Sec. 316.31  Scope of orphan-drug exclusive approval.


    (a) After approval of a sponsor's marketing application for a 
designated orphan-drug product for treatment of the rare disease or 
condition concerning which orphan-drug designation was granted, FDA will 
not approve another sponsor's marketing application for the same drug 
before the expiration of 7 years from the date of such approval as 
stated in the approval letter from FDA, except that such a marketing 
application can be approved sooner if, and such time as, any of the 
following occurs:
    (1) Withdrawal of exclusive approval or revocation of orphan-drug 
designation by FDA under any provision of this part; or
    (2) Withdrawal for any reason of the marketing application for the 
drug in question; or
    (3) Consent by the holder of exclusive approval to permit another 
marketing application to gain approval; or
    (4) Failure of the holder of exclusive approval to assure a 
sufficient quantity of the drug under section 527 of the act and 
Sec. 316.36.
    (b) If a sponsor's marketing application for a drug product is 
determined not to be approvable because approval is barred under section 
527 of the act until the expiration of the period of exclusive marketing 
of another drug product, FDA will so notify the sponsor in writing.